Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher gastrointestinal and genitourinary toxicity observed during a 24 month follow up and to estimate the rate of biochemical Disease-Free Survival, Phoenix and American Society for Therapeutic Radiology and Oncology definitions, at 2 years following hypofractionated stereotactic body radiation therapy for low and intermediate risk prostate cancer.
Radiosurgery should be ideal for treating prostate cancer because:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy | Radiation | 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Acute Grade 3 or Higher GI and GU Toxicities | Number of patients experiencing acute grade 3 or higher GI and GU toxicities. Acute toxicities are those occurring within 90 days of start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0. | Up to 90 days |
| Rate of Late Grade 3 or Higher GI and GU Toxicities | Number of patients experiencing late grade 3 or higher GI and GU toxicities. Late toxicities are those occurring after 90 days post start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0. | After 90 days post-treatment, up to 5 years per patient |
| Biochemical Disease-Free Survival Rate (bDFS) | Biochemical Disease-Free Survival (bDFS) as defined by Phoenix and ASTRO. Biochemical progression-free survival events were defined as PSA of ≥ 0.4 ng/mL following postoperative radiotherapy, PSA > 2.0 ng/mL at any time, clinical progression, initiation of non-protocol hormone therapy, and death from any cause. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Local Failure | Proportion of patients with 'local failure', which is defined as clinical evidence local recurrence. Clinical failure includes a palpable abnormality that has increased in size, failure of regression of a palpable abnormality, or redevelopment of a prostate abnormality after complete response, further confirmed by prostate biopsy. | Up to 5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adam Olson, MD | University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Hillman Cancer Center - Shadyside Radiation Oncology | Pittsburgh | Pennsylvania | 15232 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SBRT | Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SBRT | Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Acute Grade 3 or Higher GI and GU Toxicities | Number of patients experiencing acute grade 3 or higher GI and GU toxicities. Acute toxicities are those occurring within 90 days of start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0. | Patients that received SBRT therapy. | Posted | Count of Participants | Participants | Up to 90 days |
|
|
Adverse event data were collected for a period of up to 5 years.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SBRT | Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incontinence | Renal and urinary disorders | NCI CTCAE v3.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | NCI CTCAE v3.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara M Stadterman, MPH, MCCR | UPMC Hillman Cancer Center | 412-647-5554 | stadtermanbm@upmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2023 | Aug 11, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rate of Distant Failure | Proportion of patients with 'distant failure' (includes regional failure) which is defined as documented clinically via bone scan, CT or other imaging study that shows metastatic disease (disease located distant from the prostate area). | Up to 5 years |
| 5-year Overall Survival (OS) | Percentage of patients that remained alive 5 years after start of study treatment. Deaths were from any cause. | At 5 years |
| Quality of Life (QoL) - FACT-G - Prior to Therapy | The Functional Assessment of Cancer Therapy- General (FACT-G) is a self-administered 27-item questionnaire designed to measure four domains of HRQOL in cancer patients. It is comprised of physical (PWB), social (SWB), emotional (EWB), and functional (FWB) well-being subscales: (PWB; 7-items, score range 0-28), (SWB; 7-items, score range 0-28), (EWB; 6-items, score range 0-24), (FWB; 7-items, score range 0-28). The FACT-G generates an overall score of 0-108). All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much) and asks information regarding the patients last 7 days. | Prior to start of therapy |
| Quality of Life (QoL) - FACT-G - At 24 Months | The Functional Assessment of Cancer Therapy- General (FACT-G) is a self-administered 27-item questionnaire designed to measure four domains of HRQOL in cancer patients. It is comprised of physical (PWB), social (SWB), emotional (EWB), and functional (FWB) well-being subscales: (PWB; 7-items, score range 0-28), (SWB; 7-items, score range 0-28), (EWB; 6-items, score range 0-24), (FWB; 7-items, score range 0-28). The FACT-G generates an overall score of 0-108). All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much) and asks information regarding the patients last 7 days. | At 24 months (post-start of therapy) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Rate of Late Grade 3 or Higher GI and GU Toxicities | Number of patients experiencing late grade 3 or higher GI and GU toxicities. Late toxicities are those occurring after 90 days post start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0. | All enrolled patients that received SBRT therapy. | Posted | Count of Participants | Participants | After 90 days post-treatment, up to 5 years per patient |
|
|
|
| Primary | Biochemical Disease-Free Survival Rate (bDFS) | Biochemical Disease-Free Survival (bDFS) as defined by Phoenix and ASTRO. Biochemical progression-free survival events were defined as PSA of ≥ 0.4 ng/mL following postoperative radiotherapy, PSA > 2.0 ng/mL at any time, clinical progression, initiation of non-protocol hormone therapy, and death from any cause. | All enrolled patients that received SBRT therapy with PSA assessment. | Posted | Count of Participants | Participants | Up to 5 years |
|
|
|
| Secondary | Rate of Local Failure | Proportion of patients with 'local failure', which is defined as clinical evidence local recurrence. Clinical failure includes a palpable abnormality that has increased in size, failure of regression of a palpable abnormality, or redevelopment of a prostate abnormality after complete response, further confirmed by prostate biopsy. | Data were not collected. | Posted | Up to 5 years |
|
|
| Secondary | Rate of Distant Failure | Proportion of patients with 'distant failure' (includes regional failure) which is defined as documented clinically via bone scan, CT or other imaging study that shows metastatic disease (disease located distant from the prostate area). | Data were not collected. | Posted | Up to 5 years |
|
|
| Secondary | 5-year Overall Survival (OS) | Percentage of patients that remained alive 5 years after start of study treatment. Deaths were from any cause. | All patients that received SBRT therapy. | Posted | Number | percentage of participants | At 5 years |
|
|
|
| Secondary | Quality of Life (QoL) - FACT-G - Prior to Therapy | The Functional Assessment of Cancer Therapy- General (FACT-G) is a self-administered 27-item questionnaire designed to measure four domains of HRQOL in cancer patients. It is comprised of physical (PWB), social (SWB), emotional (EWB), and functional (FWB) well-being subscales: (PWB; 7-items, score range 0-28), (SWB; 7-items, score range 0-28), (EWB; 6-items, score range 0-24), (FWB; 7-items, score range 0-28). The FACT-G generates an overall score of 0-108). All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much) and asks information regarding the patients last 7 days. | Patients that received SBRT therapy, that completed quality of life assessments Prior to therapy. | Posted | Mean | Standard Deviation | score on a scale | Prior to start of therapy |
|
|
|
| Secondary | Quality of Life (QoL) - FACT-G - At 24 Months | The Functional Assessment of Cancer Therapy- General (FACT-G) is a self-administered 27-item questionnaire designed to measure four domains of HRQOL in cancer patients. It is comprised of physical (PWB), social (SWB), emotional (EWB), and functional (FWB) well-being subscales: (PWB; 7-items, score range 0-28), (SWB; 7-items, score range 0-28), (EWB; 6-items, score range 0-24), (FWB; 7-items, score range 0-28). The FACT-G generates an overall score of 0-108). All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much) and asks information regarding the patients last 7 days. | Patients that received SBRT therapy, that completed quality of life assessments Prior to therapy. | Posted | Mean | Standard Deviation | score on a scale | At 24 months (post-start of therapy) |
|
|
|
| 15 |
| 163 |
| 2 |
| 163 |
| 9 |
| 163 |
| Nocturia | Renal and urinary disorders | NCI CTCAE v3.0 | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | NCI CTCAE v3.0 | Systematic Assessment |
|
| Urinary frequncy | Renal and urinary disorders | NCI CTCAE v3.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | NCI CTCAE v3.0 | Systematic Assessment |
|
| Urinary frequency/urgency | Renal and urinary disorders | NCI CTCAE v3.0 | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | NCI CTCAE v3.0 | Systematic Assessment |
|
| Other | Renal and urinary disorders | NCI CTCAE v3.0 | Systematic Assessment |
|
| nocturia | Renal and urinary disorders | NCI CTCAE v3.0 | Systematic Assessment |
|
| weak stream | Renal and urinary disorders | NCI CTCAE v3.0 | Systematic Assessment |
|
| hypercholesteremia | Investigations | NCI CTCAE v3.0 | Systematic Assessment |
|
| Burning - tip of penis | Skin and subcutaneous tissue disorders | NCI CTCAE v3.0 | Systematic Assessment |
|
| anxiety | Psychiatric disorders | NCI CTCAE v3.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| Title | Measurements |
|---|---|
|
| FWB |
|
| FACTG |
|
| Title | Measurements |
|---|---|
|
| FWB |
|
| FACTG |
|